Main Products, Inc. is voluntarily recalling all lots of “Umary Acido Hialuronico, Suplemento Alimenticio – 30 Capletas de 850mg” to the consumer level. FDA laboratory analysis confirmed that UMARY has been found to be tainted with the drug ingredients, diclofenac and omeprazole. Products containing diclofenac and omeprazole cannot be marketed as dietary supplements. UMARY is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.
Risk Statement: Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). There is a reasonable probability that consumption of high levels of undeclared diclofenac could result in serious adverse events that include cardiovascular, gastrointestinal, renal, and anaphylaxis in patients taking concomitant NSAIDs and/or anticoagulants, such as Warfarin, in those who have allergies to diclofenac, or those with underlying cardiovascular, gastrointestinal, renal, and hepatic illnesses.
Omeprazole is a proton pump inhibitor (commonly referred to as PPI) used to treat gastric (stomach) acidrelated disorders. PPI medicines may cause serious skin reactions, abdominal pain, diarrhea, nausea, and headache. This hidden ingredient may mask stomach issues such as erosions, ulcers, and stomach cancer, and it can also interact with other medications and should not be taken with certain medications. The product is used as a dietary supplement promoted and sold for pain and is packaged in bottles with 30 caplets. The affected product includes all lots within expiry. The product was distributed via online store Main Products, Inc. on Amazon.com.
Main Products, Inc. is notifying its customers by email and is arranging for the return of all recalled products. Consumers that have UMARY which is being recalled should stop using and return to their place of purchase. Consumers may return the products to the address below.
Main Products, Inc., 1551 Glenwood Springs Ave., Chula Vista CA, 91913
www.main-products.com.
Source: FDA
